Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125011 07/15/2009 

BEXXAR  DOSIMETRIC
tositumomab i-131   injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0007-3261
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOSITUMOMAB I-131 (TOSITUMOMAB)  TOSITUMOMAB I-131 0.61 mCi  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
MALTOSE  
SODIUM CHLORIDE  
POVIDONE  
ASCORBIC ACID  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0007-3261-01 20 mL In 1 VIAL, SINGLE-USE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125011 07/15/2009 

BEXXAR  THERAPEUTIC
tositumomab i-131   injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0007-3262
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOSITUMOMAB I-131 (TOSITUMOMAB)  TOSITUMOMAB I-131 5.6 mCi  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
MALTOSE  
SODIUM CHLORIDE  
POVIDONE  
ASCORBIC ACID  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0007-3262-01 20 mL In 1 VIAL, SINGLE-USE None
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125011 07/15/2009 

Labeler - GlaxoSmithKline LLC (167380711) 
Revised: 04/2010 GlaxoSmithKline LLC